Lithium

Product NDC
0121-1027
11-digit product format
001211027
Labeler code
0121
Product ID
0121-1027_bfaabf01-1b65-43db-839a-d1b66fafec18
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lithium
Dosage form
SOLUTION
Route
ORAL
Labeler
PAI Holdings, LLC dba PAI Pharma
Application
ANDA070755
Marketing category
ANDA
Marketing start
2026-04-14
Substance
LITHIUM CITRATE
Active strength
8 meq/5mL
Pharmacologic classes
Mood Stabilizer [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lithium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LITHIUM CITRATE8 meq/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5Z6E9K79YV
Rxcui756059

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b3053bb1-353b-4a0b-bca5-28fe7228957cProduct name220250124
8ce6e144-236f-b7be-f690-f06e0c8c6bd3Product name220170725
f09af6ee-c6dd-d0ce-77ad-93508bcdacedProduct name420161205

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-1027-16Lithium500 mL in 1 BOTTLESOLUTION5005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-1027-16ML - Milliliter0121-1027c7009311-270c-4f34-8954-0c4d94ca477e12026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
756059lithium ion 8 MEQ in 5 mL Oral SolutionPSN677b20c4-84f0-4716-aca3-aead3bbe12835
756059lithium citrate 60 MG/ML Oral SolutionSCD677b20c4-84f0-4716-aca3-aead3bbe12835
756059lithium citrate eqv to lithium carbonate 300 MG per 5 ML (lithium ion 8 MEQ per 5 ML) Oral SyrupSY677b20c4-84f0-4716-aca3-aead3bbe12835
756059lithium ion 8 MEQ per 5 ML Oral SyrupSY677b20c4-84f0-4716-aca3-aead3bbe12835

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0121-1027-1600121102716500 mL in 1 BOTTLE (0121-1027-16) 500 ml2026-04-14NoNoHistorical